SPROTTE® NRFit 021163-29A

GUDID 14048223026950

SPROTTE® NRFit 25G x 3 ½" (90mm) with IntroDucer NRFit 30mm

Pajunk GmbH Medizintechnologie

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• Primary Device ID: 14048223026950
• NIH Device Record Key: 97fd947e-9fb9-467e-8cbd-508675f040d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPROTTE® NRFit
• Version Model Number: 021163-29A
• Catalog Number: 021163-29A
• Company DUNS: 317654283
• Company Name: Pajunk GmbH Medizintechnologie
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048223026953 [Unit of Use]
GS1	14048223026950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160295

FDA Product Code

• BSP: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-14

On-Brand Devices [SPROTTE® NRFit]

• 14048223031657: SPROTTE® NRFit 24G x 1 3/8" (35mm) sterile
• 14048223030353: SPROTTE® NRFit 27G x 4 ¾" (120mm) with IntroDu
• 14048223030346: SPROTTE® NRFit 27G x 3 ½" (90mm), with IntroDu
• 14048223030339: SPROTTE® NRFit 25G x 6" (150mm)
• 14048223030315: SPROTTE® NRFit 25G x 3 ½" (90mm), with IntroDu
• 14048223030308: SPROTTE® NRFit 24G x 8" (200mm) with IntroDuc
• 14048223030292: SPROTTE® NRFit 24G x 1" (25mm)
• 14048223030261: SPROTTE® NRFit 22G x 4" (103mm) with IntroDuc
• 14048223030254: SPROTTE® NRFit 22G x 3½" (90mm)
• 14048223029913: SPROTTE® NRFit 27G x 3 ½" (90mm) with IntroDu
• 14048223029821: SPROTTE® NRFit 24G x 3½" (90mm)
• 14048223027025: SPROTTE® NRFit 27G x 4 ¾" (120mm)
• 14048223027018: SPROTTE® NRFit 27G x 4" (103mm) with IntroDuc
• 14048223027001: SPROTTE® NRFit 25G x 6" (150mm) with IntroDuc
• 14048223026998: SPROTTE® NRFit 25G x 4 ¾" (120mm)
• 14048223026981: SPROTTE® NRFit 25G x 4 ¾" (120mm) with IntroDu
• 14048223026974: SPROTTE® NRFit 25G x 4" (103mm) with IntroDuc
• 14048223026967: SPROTTE® NRFit 25G x 3 ½" (90mm)
• 14048223026950: SPROTTE® NRFit 25G x 3 ½" (90mm) with IntroDu
• 14048223026943: SPROTTE® NRFit 25G x 1 3/8" (35mm)
• 14048223026936: SPROTTE® NRFit 24G x 6" (150mm) with IntroDuc
• 14048223026929: SPROTTE® NRFit 24G x 4 ¾" (120mm) with IntroDu
• 14048223026912: SPROTTE® NRFit 24G x 4" (103mm) with IntroDuc
• 14048223026905: SPROTTE® NRFit 24G x 3 ½" (90mm) with IntroDu
• 14048223026899: SPROTTE® NRFit 22G x 6" (150mm) with IntroDuc
• 14048223026882: SPROTTE® NRFit 22G x 4 ¾" (120mm) with IntroDu
• 14048223026875: SPROTTE® NRFit 22G x 3 ½" (90mm) with IntroDu